MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Conceal; prosthesis, penis, inflatable

Model Number	720185-01
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/10/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Model number/catalog number: 72404251.Serial number: n/a.Batch/lot number: 1100788729.Model/catalog description: lgx preconnect ms 15cm ps iz.Unique identifier (udi) #: (b)(4).
Event or Problem Description
It was reported that a patient with an inflatable penile prosthesis (ipp) experienced right inguinal pain.The reservoir was found to have migrated to the right inguinal region.A surgical procedure was performed to remove and replace the reservoir.No further patient complications were reported.
Event or Problem Description
It was reported that a patient with an inflatable penile prosthesis (ipp) experienced right inguinal pain.The reservoir was found to have migrated to the right inguinal region.A surgical procedure was performed to remove and replace the reservoir.No further patient complications were reported.
Additional Manufacturer Narrative
Model number/catalog number: 72404251.Serial number: n/a.Batch/lot number: 1100788729 model/catalog description: lgx preconnect ms 15cm ps iz.Unique identifier (udi) #: (b)(4).The device is not available for analysis; therefore, no physical analysis of the product could be performed.The reported device performance allegation cannot be confirmed.The device history record (dhr) review was unable to be performed as the lot number was not provided.A review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.A risk review was completed and confirmed that the events of pain/discomfort and migration were defined in the product risk documentation.This event type has been accounted for during analysis to support acceptable risk benefit for the product.Based on the information available the cause that contributed to the reported event cannot be established.Therefore, a conclusion code of cause not established was assigned to this investigation.

• Brand Name: Conceal
• Common Device Name: prosthesis, penis, inflatable
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): Boston Scientific Corporation; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 25883954
• Report Number: 2124215-2026-38967
• Device Sequence Number: 10099812
• Product Code: JCW
• UDI-Device Identifier: 00878953005669
• UDI-Public: (01)00878953005669(17)270520(10)1100732044
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 720185-01
• Device Catalogue Number: 720185-01
• Device Lot Number: 1100732044
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/20/2026
• Supplement Report FDA Received Date: 08/24/2026
• Date Device Manufactured: 05/20/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 58 YR
• Patient Sex: Unknown